Duns Number:658637244
Device Description: 1 meter - 008834890019861 lancing device - 008834890020131 control solution -0088348900202 1 meter - 008834890019861 lancing device - 008834890020131 control solution -00883489002020
Catalog Number
-
Brand Name
RIGHTEST
Version/Model Number
GM700SB
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K190564,K190564
Product Code
NBW
Product Code Name
System, Test, Blood Glucose, Over The Counter
Public Device Record Key
d0f10a37-5c9c-44c1-b7fa-1f7ed5db6a77
Public Version Date
September 20, 2019
Public Version Number
1
DI Record Publish Date
September 12, 2019
Package DI Number
20883489001997
Quantity per Package
50
Contains DI Package
00883489001993
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |